Viewing Study NCT06420037



Ignite Creation Date: 2024-05-19 @ 5:35 PM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06420037
Status: RECRUITING
Last Update Posted: 2024-05-17
First Post: 2024-04-16

Brief Title: The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
Sponsor: University Ghent
Organization: University Ghent

Study Overview

Official Title: The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this clinical trial is to optimize hearing aid benefit based on the individual auditory-cognitive need using different hearing aid features in first-time hearing aid users between 45-80 years old with bilateral Phonak Audéo ParadiseLumity 70 hearing aids The main questions it aims to answer are

Does cognitive functioning affect hearing aid benefit How can hearing aid fitting be optimized based on the individual auditory-cognitive profile

The hypothesis posits that cognitive abilities influence the effectiveness of hearing aids alongside hearing status Furthermore if features of hearing aids improve speech understanding and listening effort it is proposed that individuals with lower cognitive functioning will experience heightened benefits from hearing aids

The study will consist of three groups one control group and two groups where one different feature will be modified

Participants will be tested at baseline measurement including

screening tests
audiological tests
questionnaires
cognitive tests
real-ear-measurement

Following this participants will be divided in one of the three groups after which speech audiometry will be repeated After a 4-week acclimatization period the second measurement will take place repeating speech audiometry and questionnaires Subsequently the hearing aid settings will be restored to their initial configuration
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None